Dynamico tablets: reviews from men, instructions for use, price, analogues

pharmachologic effect

The drug Dynamico is used to treat erectile dysfunction . The active substance inhibits PDE-5. Due to increased blood flow to the penis, the active substance is able to restore impaired erectile function with provided sexual stimulation.

Erection at the physiological level is based on the release of NO - nitric oxide in the cavernous bodies as a result of excitement. NO is able to activate guanylate cyclase, which increases the level of cyclic guanosine monophosphate (cGMP), which relaxes smooth muscle fibers in the blood vessels, which leads to increased blood flow to the cavernous bodies in the penis.

Sildenafil is a selective inhibitor of cGMP (specific PDE-5), under the influence of which cGMP breaks down in the cavernous bodies in the penis. The active substance does not have a direct effect on the relaxation of smooth muscles in the corpora cavernosa, but it is able to increase blood flow to the penis and enhance the ability of NO to relax smooth muscles. During sexual stimulation, activation of the NO-cGMP chain is observed, which inhibits PDE-5, which increases the level of cGMP in the cavernous bodies. The above pharmacological effect is observed only with sexual stimulation .

Sildenophil is more active than all known PDE isoenzymes: it is 10 times more active than PDE-6, 80 times more active than PDE-1, 700 times more active than PDE-2, 4, 7, 11. The active substance is 4 more selective in comparison with PDE-3 thousand times, which is important because PDE-3 is the main enzyme in the regulation of cardiac contractility.

Sildenafil is characterized by a mild hypotensive effect , which has a short-term effect and has virtually no clinical significance when treated with the drug in doses recommended by the manufacturer. The hypotensive effect is due to a vasodilating effect caused by an increased content of cGMP in smooth muscle fibers in the vascular wall.

Dynamic tab 50 mg N4 (Teva)

Dynamico is a PDE-5 inhibitor that improves erectile function. Pharmacodynamics Drug for the treatment of erectile dysfunction. Restores impaired erectile function under conditions of sexual stimulation by increasing blood flow in the penis. The physiological mechanism of erection involves the release of nitric oxide (NO) in the corpus cavernosum due to sexual arousal. NO activates the enzyme guanylate cyclase, which leads to an increase in cGMP concentration. In turn, cGMP causes relaxation of the smooth muscles of the blood vessels and, accordingly, blood flow into the cavernous body of the penis. Sildenafil is a selective inhibitor of cGMP-specific PDE5, which causes the breakdown of cGMP in the corpus cavernosum of the penis. It does not have a direct relaxing effect on the smooth muscles of the corpus cavernosum, but it enhances the relaxing effect of NO and increases blood flow in the penis. When the NO–cGMP chain is activated, which is observed during sexual stimulation, inhibition of PDE5 leads to an increase in the level of cGMP in the corpus cavernosum. The pharmacological effect is achieved only in the presence of sexual stimulation. The activity of sildenafil against PDE5 exceeds the activity against other known PDE isoenzymes: PDE6 - 10 times, PDE1 - more than 80 times; PDE2-PDE4, PDE7-PDE11 - more than 700 times. Sildenafil is 4000 times more selective for PDE5 compared to PDE3, which is of great importance since PDE3 is one of the key enzymes in the regulation of myocardial contractility. Sildenafil has a mild and short-term hypotensive effect, in most cases without clinical manifestations when taken in recommended doses. The hypotensive effect is associated with the vasodilating effect of sildenafil due to an increase in the content of cGMP in the smooth muscle of the blood vessels. Pharmacokinetics Absorption After oral administration, it is rapidly absorbed. Cmax in blood plasma when taken on an empty stomach is achieved within 0.5–2 hours, bioavailability averages 41% (25–63%). When taken with food, Cmax is reduced by 20–40% and is achieved after 1.5–3 hours. Distribution Apparent Vss is 105 l. The binding of sildenafil and its main active metabolite to plasma proteins is 96% of the administered dose and is not dose-dependent. Metabolism Sildenafil is metabolized mainly by the liver microsomal isoenzymes CYP3A4 (main pathway) and CYP2C9 (additional pathway). The main circulating active metabolite is N-demethyl metabolite, whose activity against PDE is 50% of the activity of sildenafil, and its plasma concentration reaches 40% of the concentration of sildenafil. The N-demethyl metabolite undergoes further metabolism with T1/2 4 hours. Elimination The total clearance of sildenafil is 41 l/hour. T1/2 of sildenafil is 3–5 hours. Inactive metabolites are excreted by the intestines (80%) and kidneys (13%). Special groups of patients In patients over 65 years of age, the Cmax of sildenafil and its active metabolite is increased by approximately 90% compared to patients 18–45 years of age due to reduced clearance of sildenafil. The concentration of sildenafil not bound to proteins in the blood plasma is 40%. In patients with moderate renal failure (creatinine clearance 30–80 ml/min), the pharmacokinetics of sildenafil does not change when taking 50 mg, and Cmax and AUC for the N-demethyl metabolite are increased by 73 and 126%, respectively. In patients with severe renal failure (creatinine clearance less than 30 ml/min), Cmax and AUC of sildenafil are increased by 88 and 100%, respectively, Cmax and AUC of N-demethyl metabolite are increased by 79 and 200%, respectively. In patients with liver cirrhosis (classes A and B on the Child-Pugh scale), Cmax and AUC were increased by 47 and 84%, respectively.

Pharmacodynamics and pharmacokinetics

Suction process

Rapidly absorbed after oral administration. When taken on an empty stomach, the maximum level is recorded after 0.5-2 hours. Bioavailability depends on food intake: on an empty stomach - 41%, after eating - 20-40% (reached within 1.5-3 hours).

Distribution

The VSS indicator is 105 liters. Active metabolites and Sildenafil itself are bound to plasma proteins by 90% of the dose taken. The indicator is not dose-dependent.

Metabolism

metabolic pathway is carried out with the participation of the microsomal isoenzyme CYP2C9, and the main one is CYP3A4. The most important active circulating metabolite is the N-demethyl metabolite, which exhibits activity in relation to PDE equal to 50% of the activity of Sildenafil. Its concentration reaches 40% of the level of Sildenafil. The half-life of N-demethyl metabolite is 4 hours.

Removal

The clearance of the active substance is 41 l/h. The half-life is 3-5 hours. Inactive metabolites are excreted 13% through the renal system and 80% through the intestines.

Special group of patients

Compared with patients 18-45 years old, in people over 65 years old, the Cmax is 90% higher, which is explained by the reduced clearance of Sildenafil. The level of active substance not bound to plasma proteins is 40%. With moderate pathology of the renal system, the pharmacokinetics do not change (when taking 50 mg of the drug). With cirrhotic damage to the hepatic system, Cmax and AUC increase by 47 and 84%, respectively.

Dynamico

A drug for the treatment of erectile dysfunction, a PDE5 inhibitor. Restores impaired erectile function under conditions of sexual stimulation by increasing blood flow in the penis.

The physiological mechanism of erection involves the release of nitric oxide (NO) in the corpus cavernosum due to sexual arousal. NO activates the enzyme guanylate cyclase, which leads to increased concentrations of cyclic guanosine monophosphate (cGMP). In turn, cGMP causes relaxation of the smooth muscles of the blood vessels and, accordingly, blood flow into the cavernous body of the penis.

Sildenafil is a selective inhibitor of cGMP-specific PDE5, which causes the breakdown of cGMP in the corpus cavernosum of the penis. It does not have a direct relaxing effect on the smooth muscle of the corpus cavernosum, but it enhances the relaxing effect of nitric oxide on this tissue and increases blood flow in the penis. When the NO-cGMP chain is activated, which is observed during sexual stimulation, inhibition of PDE5 leads to an increase in cGMP in the corpus cavernosum. The pharmacological effect is achieved only in the presence of sexual stimulation.

The activity of sildenafil against PDE5 exceeds the activity against other known phosphodiesterase isoenzymes: PDE6 - 10 times; PDE1 - more than 80 times; PDE2 - PDE4, PDE7-PDE11 - more than 700 times. Sildenafil is 4000 times more selective for PDE5 compared to PDEZ, which is of great importance since PDEZ is one of the key enzymes in the regulation of myocardial contractility.

Sildenafil has a mild and short-term hypotensive effect, in most cases without clinical manifestations when taken in recommended doses. The hypotensive effect is associated with the vasodilating effect of sildenafil due to an increase in the content of cGMP in the smooth muscle of the blood vessels.

Pharmacokinetics

Suction

After oral administration, it is quickly absorbed. Cmax in blood plasma when taken on an empty stomach is achieved within 0.5-2 hours, bioavailability averages 41% (25-63%). When taken with food, Cmax is reduced by 20-40% and is achieved after 1.5-3 hours.

Distribution

The apparent Vd at equilibrium is 105 l. The binding of sildenafil and its main active metabolite to plasma proteins is 96% of the administered dose and is not dose-dependent.

Contraindications

taking Ritonavir ;
individual hypersensitivity;
patients suffering from loss of vision in one eye due to optical ischemic anterior neuropathy of non-arterial origin (regardless of the influence of a PDE-5 inhibitor);
age limit – up to 18 years of age;
female;
intake of organic nitrates, NO donors;
severe pathology of the hepatic system;
degenerative changes in the retina of hereditary origin (for example, retinitis pigmentosa ).

The medication is not prescribed to persons for whom sexual activity is undesirable:

life-threatening arrhythmias;
heart failure;
arterial hypertension;
arterial hypotension;
unstable form of angina;
myocardial infarction;
cerebrovascular accidents.

Relative contraindications:

obstructive lesion of the left ventricular outflow tract;
multiple system atrophy syndrome;
obstructive hypertrophic cardiomyopathy ;
aortic stenosis;
multiple myeloma;
priapism;
anatomical deformation of the shape of the penis;
galactose-glucose malabsorption;
lactose deficiency;
lactose intolerance;
leukemia;
taking alpha-blockers.

Side effects

Organs of vision:

disruption of tear flow;
damage to the conjunctiva;
color vision impairment;
disturbance of visual perception;
transient form of chromatopsia ;
blurred vision;
increased perception of light;
redness of the sclera;
occlusion of blood vessels in the retina;
ischemic form of anterior optic neuropathy;
narrowing of visual fields;
pain in the eyeballs.

Heart, vascular system:

atrial fibrillation;
feeling of rapid heartbeat;
sudden coronary death;
unstable form of angina;
ventricular arrhythmias;
myocardial infarction;
instability of blood pressure .

Nervous system:

transient ischemic attack;
fainting;
stroke;
hypoesthesia;
seizures (including recurrent ones);
increased drowsiness;
dizziness;
migraine headaches.

Other reactions:

deafness;
noise in ears;
vertigo;
nosebleeds ; _
nasal congestion;
vomit;
dyspeptic disorders;
dry mouth;
fast fatiguability;
chest pain;
priapism;
prolonged erection;
skin rashes;
nausea;
Lyell's syndrome.

ORAL MEDICATIONS MAY BE UNSAFE

Not all men can be guaranteed to safely take tablet drugs to improve potency, such as sildenafil, vardenafil, tadalafil, etc. These medications may not work or may harm your health if you:

You are taking nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate, which are often prescribed for chest pain (angina).
Have very low blood pressure (hypotension) or uncontrolled high blood pressure (hypertension).
You have serious liver disease.
Have kidney disease requiring hemodialysis.

Dynamico tablets, instructions for use (Method and dosage)

The medication must be taken 1 hour before the intended sexual activity.

Instructions for use Dynamico 50 mg: 1 tablet per day. The dosage can be reduced to 25 mg or increased to 100 mg, taking into account the tolerability and effectiveness of the drug.

For mild/moderate pathology of the renal system, no adjustment of the dosage regimen is required. In case of severe renal pathology, treatment begins with taking 25 mg of Sildenafil with a gradual increase to 50 or 100 mg if well tolerated. The first dose for older men is 25 mg, with gradual increases as needed and well tolerated.

Treatment also begins with 25 mg for mild/compensated pathology of the hepatic system, gradually increasing the dose to 50-100 mg as needed. A similar regimen should be followed for patients taking drugs from the alpha-blocker group.

The role of sildenafil in the life of men and women

A person experiences earthquakes, epidemics, the horrors of illness and all sorts of torments of the soul, but for all times the most painful tragedy for him was, is and will be - the tragedy of the bedroom. (L.N. Tolstoy in the memoirs of his contemporaries)

Introduction

The first mention of erectile dysfunction (ED) was noted in the manuscripts of Ancient Egypt [1]. Since then, there have been continuous attempts to improve a man's sexual potential, but a revolutionary breakthrough came with the discovery by Furchgott, Ignarro and Murad of the role of nitric oxide in the functioning of the cardiovascular system. The authors received the Nobel Prize and, in the course of further research, created sildenafil, which has continued its triumphal march across the planet since 1998 [2]. Sildenafil is familiar to many as a drug for the treatment of ED, but the range of its therapeutic possibilities is wider [3]. The efficacy and safety of sildenafil were assessed in 48 randomized, double-blind, parallel-group, double-blind, parallel-group studies involving 11,364 men with ED [3]. It was shown that in all age groups, including people over 75 years of age, the effectiveness of sildenafil citrate (SC) was high, and the frequency of side effects, among which headache and hot flashes predominated, was low [4]. Taking SC leads to an improvement in erectile function in patients of different ages, regardless of the etiology, severity and duration of ED. Sildenafil affects both arterial and venous blood flow in the penis, which makes it primarily indicated for vasculogenic ED. The drug improves cavernous electrical activity, which justifies its use in the neurogenic form of the disease [5]. Another recent study confirmed that phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are generally well tolerated. The authors emphasize that there are no studies comparing various drugs in this group; all comparisons were made with placebo [6]. Confirmation of the effectiveness and safety of sildenafil was obtained in a population-based study using the example of residents of Chinese megacities [7]. Studying the effectiveness of various doses of SC in 3674 patients with ED, we came to the conclusion that the satisfaction of patients who took 100 mg of sildenafil was higher than that of those who took 50 mg of SC [8]. In general, it is recommended to approach dose selection in a personalized manner [9]. Physical exercise, diet, and normalization of plasma glucose levels are not sufficient to restore erectile function in patients with diabetes [10]. A systematic review of 17 well-designed studies confirmed the effectiveness and safety of sildenafil in diabetic patients with ED [11]. SC did not increase adverse reactions in diabetic patients taking metformin and thiazolidine [12]. In the treatment of urological diseases combined with ED (hypogonadism, benign prostatic hyperplasia), a potentiation of the effect of the combined use of basic therapy and sildenafil was noted [1, 13]. It is emphasized that daily use of sildenafil by patients with ED after prostatectomy gives a less pronounced effect than on-demand use [14], which is absolutely logical, since PDE-5 inhibitors cause an erection only in the presence of sexual stimulation. A fracture of the pelvic bones with damage to the urethra naturally leads to the development of ED. However, even in such a severe group, daily administration of sildenafil is effective in 61.5% of cases [15]. Not a single drug from the PDE-5 inhibitor group provides a 100% effect in the treatment of ED. To find out the reasons for this phenomenon, a molecular genetic study was conducted in Spain, which showed genetic polymorphism in responses to PDE-5 inhibitors. As it turned out, the effectiveness of treatment with PDE-5 inhibitors is genetically determined and cannot be changed. There was also a clear correlation between glycemic status and the effectiveness of treatment with sildenafil [16]. Recently, non-drug methods of treating patients with ED have become popular, in particular extracorporeal shock wave therapy [17]. An experimental study was conducted showing that this method, when taking sildenafil, significantly increases the effectiveness of treatment [18]. Some patients prefer oral tablets that do not require swallowing and drinking water, and these are already on the market [19]. Chronic prostatitis, both common and specific, can be complicated (accompanied) by ED [20–24]. Hypothetically, one can expect a positive effect of SC in prostatitis, since it has been shown that sildenafil affects the course of the inflammatory process, since it reduces the activity of pro-inflammatory factors. After taking sildenafil, TNF-α immediately decreases, and the level of C-reactive protein decreases [25]. However, along with the anti-inflammatory effect, sildenafil reduces the activity of ciprofloxacin in the treatment of patients with chronic prostatitis complicated by ED [26], this must be taken into account when prescribing therapy for such patients. Those who are moderate in matters of sexual problems claim that the problem of ED is exaggerated, and that a person may well be happy, for example, doing his favorite job or hobby. However, our research has shown that this is not the case: a multicenter cohort study found a positive correlation between the quality of men’s sexual function and their level of overall success [20]. In women, however, such a dependence is not observed [27], partly, apparently, because a woman’s gender role does not depend on her sexual satisfaction. We set out to
study how sexual partners of men with ED assessed their sex lives before their men began taking PDE5 inhibitors and after the course of treatment.

Material and methods

An open, single-center cohort study was conducted involving 128 men with mild to moderate ED aged 32 to 54 years (average 42.1 years). All patients had not previously taken PDE-5 inhibitors. The patients were prescribed sildenafil 50 mg “on demand” 1 hour before expected intercourse. A second visit to the doctor was scheduled after 2 weeks. therapy for possible dose adjustment. The third, final visit was scheduled after 3 months. from taking the first dose of sildenafil. The effectiveness of treatment was assessed using the International Index of Erectile Function scale; patients recorded adverse reactions in their diaries. If a strong or prolonged (more than 6 hours) undesirable effect occurred, patients came for an unscheduled appointment with a doctor. After 3 months wives (regular sexual partners) of men with effective treatment were surveyed regarding satisfaction with the quality of treatment of their husbands. The wives were asked to independently assess the couple's initial sex life and the changes that occurred after treatment using a questionnaire. The ultimate goal of the study was to analyze this assessment.

results

Of the 128 men, only one (0.78%) developed nasal congestion, impaired color vision and headache while taking sildenafil so severely that he stopped taking the drug. Another 15 (11.7%) had side effects, but the patients considered them minor and continued therapy. For 24 (18.75%) men with very good erections, but with adverse reactions, the dose was reduced to 25 mg, which did not affect the effectiveness, but improved tolerability. In 32 (25.0%) patients, on the contrary, the attending physician considered it necessary to increase the dose to 100 mg, the remaining 72 (56.25%) continued therapy with the initial dose of SC 50 mg. Taking sildenafil and, accordingly, sexual intercourse (or an attempt at it) occurred on average with a frequency of 2.7 times a week. A positive effect of sildenafil was noted by 83 (64.84%) patients. When asked to invite their wives for a conversation, two admitted that they lived in a homosexual couple, 27 men did not have a permanent girlfriend and realized their restored sexual potency in casual relationships, 11 women refused to talk, and 43 agreed to answer the questions. Initially, 38 wives (88.37%) rated the couple’s sex life as unsatisfactory, although 5 women did not consider their husband’s ED a problem, since they themselves had low sexual desire. After 3 months sildenafil therapy, 19 (44.18%) women considered family sex life good, 22 (51.16%) - excellent. At the same time, according to 2 (4.65%) women, no changes occurred, which once again proves that for a woman in sex, a good erection in a sexual partner is not enough. The assessment results are presented in Figure 1.

Thus, 41 (95.35%) women were satisfied with the result of their husband’s treatment with the drug SC and considered that the improvement in the quality of erection had a positive impact on family life.

Discussion

Drug correction of sexual deviations in women remains questionable; the psychological component of the process probably plays a leading role here [28]. Our study showed that 95.35% of women are satisfied with the results of treating their sexual partners with sildenafil, therefore, sildenafil affects the sexual function of women, albeit indirectly. There are a number of pitfalls in the use of PDE-5 inhibitors. Firstly, there are many counterfeits and low-quality generics on the market [29]. A spectral analysis of base sildenafil and SC was carried out [30]. Sildenafil crystallizes as base sildenafil, SC - with a higher crystal characteristic (Fig. 2). The presence of various impurities disrupts the quality characteristics of SC.

When treating sildenafil, the general rules for taking medications are followed. It is recommended to take medications with water rather than any other drink to avoid interactions and prevent inactivation of the drug or its biotransformation during competitive metabolism involving the cytochrome isoenzymes CYP3A4 and CYP2C9. Inhibitors of CYP3A4 and CYP2C9 isoenzymes (ketoconazole, erythromycin, cimitidine) reduce metabolism and increase the concentration of sildenafil in the blood. In this case, treatment with sildenafil begins with a dose of 25 mg, since otherwise, due to competitive metabolism, an overdose of SC is possible, which has a hepatotoxic effect [31]. The level of sildenafil in the blood plasma was compared in men who took the tablets with water diluted with lemon or orange juice. It was found that orange juice significantly increased the concentration of sildenafil in the blood (the peak concentration was 44% higher, the “cleansing period” was 30% longer). Lemon juice, to the surprise of the researchers, had no effect on the pharmacokinetics of sildenafil [32]. Since 2011, the group’s production center (Dynamico) has been represented on the Russian pharmaceutical market, which in 2014 received the “Platinum Ounce” - the highest award in the pharmaceutical industry and again won the competition award in 2015. A study conducted in Russia showed that Dynamico provides high-quality erection, has a minimum of side effects and is not addictive [33-34].

conclusions

Sildenafil plays an important, albeit indirect, role in a woman’s life - it increases her sexual satisfaction by improving erection in her sexual partner. According to the study, 95.35% of women are satisfied with the results of treating their sexual partners with sildenafil.

Interaction

The concentration of Sildenafil in the blood increases when treated with inhibitors of the isoenzymes CYP2C9 and CYP3A4:

Erythromycin;
Ketoconazole;
Cimetidine.

Such patients are recommended to take 25 mg of Sildenafil.

The maximum concentration of Sildenafin increases by 300% and the AUC by 1000% with simultaneous use of Ritonavir. These indicators also increase during treatment with Saquinavir. Dynamico does not affect the pharmacokinetics of Saquinavir and Ritonavir. Sildenafil is able to enhance the antiplatelet effect of Nitroprusside Na. It is possible to develop severe arterial hypotension when taking Nicorandil , which contains a nitrate component. There is a mutual increase in effects (possible death) when taking nitrates and other NO donors. The drug Dynamic may enhance the hypotensive effect of ACE inhibitors, beta blockers and medications of the CCB group. There is an increase in the activity of hypoglycemic drugs . It is possible to develop orthostatic hypotension and a pronounced drop in blood pressure when taking the alpha-blocker Doxazosin . The concentration of the active substance Sildenafil increases if you take the tablets with grapefruit juice.

DON'T IGNORE THE MAIN CAUSES OF ERECTILE DYSFUNCTION

Treating the underlying cause of erectile dysfunction can help prevent health problems and improve sexual function. Conditions that can cause or worsen erectile dysfunction include:

heart diseases;
diabetes;
obesity;
psychological problems;
alcoholism and drug abuse;
smoking.

If you have developed erectile dysfunction, consider one of the treatment options listed above. Find out from your doctor which method can be truly effective in your case.

special instructions

A thorough examination is required to determine the true causes of erectile dysfunction. Patients taking other medications, as well as those suffering from serious diseases of the heart and vascular system, are advised to assess the risk of developing negative reactions associated with sexual activity. Sildenafil is able to gradually lower blood pressure. In patients with rare multiple atrophy syndrome and obstructive lesions of the left ventricle, the hypotensive effect is more pronounced. Most negative reactions from the heart and vascular system develop immediately after sexual intercourse or a certain time after it. It is extremely rare that adverse reactions occur before sexual intercourse. Concomitant use of other medications prescribed for erectile dysfunction .

The medication is used with caution by persons suffering from various diseases that predispose to the development of priapism:

multiple myeloma;
sickle cell anemia;
leukemia (bone marrow disease).

In case of anatomical deformation of the penis (against the background of cavernous fibrosis , angulation , Peyron's disease ), Dynamic is prescribed with caution. If visual perception disorders develop, immediate consultation with your doctor is required. Taking more than 200 mg of the active substance does not affect the effectiveness, but increases the severity and frequency of dose-dependent negative reactions. It is recommended to refrain from driving a vehicle.

OTHER TYPES OF DRUG THERAPIES

Other types of medications (non-oral) to treat erectile dysfunction include:

Injection pharmacotherapy . To achieve an erection, some medications are injected directly into the penis. The most commonly used drugs are alprostadil, papaverine and phentolamine. The medicine is injected with a thin needle into the base or side of the penis. The injection is virtually painless.
An injection of the drug stimulates an erection, which lasts from 20 to 40 minutes. If an erection lasts longer than an hour, the dose must be adjusted to avoid potential complications. Side effects may include bleeding at the injection site, prolonged erection (priapism), fibrous tissue formation inside the penis and injection site.
Intraurethral suppositories. Intraurethral therapy, based on the active substance alprostadil, consists of placing a miniature suppository inside the penis (urethra) using a special applicator. The required penile rigidity is usually achieved within 10 minutes and lasts from 30 to 60 minutes. Side effects may include pain, minor bleeding in the urethra, and the formation of fibrous tissue inside the penis.
Testosterone replacement therapy . Some men have erectile dysfunction, which can be complicated by low testosterone levels. In this case, testosterone replacement therapy may be recommended as a first step. You should consult your doctor about possible side effects.

Analogues of Dynamico

Level 4 ATX code matches:
Tornetis

Olmax Strong

Taxier

Revatio

Caverject

Levitra

Cialis

Tentex Forte

Rileys

Viagra

Sildenafil

Yohimbine hydrochloride

Zidena

Papazole

Structural analogues:

Wildegra;
Viagra;
Silaphil;
Rijump;
Maxigra;
Vizarsin;
Olmax Strong;
Vigrande;
Erexesil;
Taxier;
Revatio;
Tornetis.

Vizarsin or Dynamico - which is better?

The composition of the drugs is absolutely identical, both contain Sildenafil. Both medications are generics - substitutes for the original Viagra . Vizarsin costs much less (90-280 rubles).

Reviews about Dynamiko

The drug has established itself as a good analogue of Viagra, used for erectile dysfunction.

Reviews of the drug Dynamico (100 mg, 4 tablets)

The medication does not provoke an erection on its own; the mechanism of action is aimed at increasing arousal and blood flow. According to statistics, potency returned to normal in 89% of patients. Patients note that if you take Dynamico before a meal, its effectiveness will appear within 30-40 minutes, and if after a meal, the effect may last for 3-4 hours.

Dynamico tablets, reviews from men

On thematic forums, males leave mostly positive reviews about the drug, confirming its effectiveness in treating potency disorders. Most often, patients write that the drug reduces the severity of shortness of breath during sexual intercourse, which is due to the effect of enzymes on the vessels of the respiratory tract and on the pulmonary artery ( vasodilating effect ). After the drug stops working, this effect is lost. The duration of action of the medication varies individually and ranges from 5-9 hours.

VACUUM PUMPS AND SURGERY

If drug therapy is not effective or appropriate, your doctor may recommend other treatment options:

Vacuum erection therapy . The vacuum device is a hollow tube into which the penis is placed. Then, using a pump, the air is sucked out, the resulting vacuum ensures a rush of blood to the penis. After achieving an erection, a special ring is placed on the base of the penis, which delays the flow of blood.
The erection usually lasts long enough for intercourse to take place. Possible side effects include bruising of the penis, as well as limited ejaculation. The penis may become cold to the touch.
Implantation of a penile prosthesis. Surgical treatment of erectile dysfunction involves implanting special rods on both sides of the penis. Implants consist of either inflatable or semi-rigid rods. Inflatable devices are technically more advanced and allow you to control when and how long an erection will last.
Penile prosthetics, as a rule, are recommended only in cases where conservative therapy has been unsuccessful. The operation has a high degree of satisfaction among men who have tried and failed to achieve the desired results using conservative treatment methods. As with any operation, there is a risk of complications, in particular the risk of infection.
Vascular surgery. Vein surgery can be used effectively in selected cases of erectile dysfunction, especially in combination with erection pills. Surgeries on arteries are ineffective and are used less and less.

Dynamico price, where to buy

The price of Dynamico in pharmacies depends on the region, the dosage of the active substance and the number of tablets. For example, the price of Dynamico 100 mg 4 tablets is 1000 rubles. The medicine in the smallest dosage of 25 mg can be bought in Moscow for 300 rubles.

Online pharmacies in RussiaRussia

ZdravCity

Dynamic tablets p.p.o.
100 mg 1 pc. Pliva Hrvatska d.o.o. 550 rub. order
Dynamic tablets p.p.o. 100 mg 4 pcs. Pliva Hrvatska d.o.o.
958 RUR order
Dynamic tablets p.p.o. 50 mg 1 pc. Pliva Hrvatska d.o.o.
RUR 441 order
Dynamic tablets p.p.o. 50 mg 4 pcs. Pliva Hrvatska d.o.o.
RUR 797 order
Dynamico film-coated tablets 50 mg No. 12 Pliva Hrvatska d.o.o.
RUR 1,118 order

Introduction

Erectile dysfunction (ED) is defined as the inability to achieve and/or maintain an erection sufficient for sexual activity.
According to various estimates, the prevalence of ED ranges from 16.2–20.7 to 31% [4, 5], while the risk of its development increases with age: the older the patient, the greater the chance of identifying a severe degree of impairment due to the presence of chronic vasculogenic and neurogenic disorders, as well as age-related hormonal, psychogenic or mixed causes, incl. induced by chronic medication use [6]. ED negatively affects the quality of life, self-esteem, relationships with a sexual partner [7, 8], and may be accompanied by depression, chronic stress, and burnout syndrome [9]. Patients with ED often require treatment with phosphodiesterase type 5 inhibitors (PDE5) for a long time. Considering the polyetiological nature of ED, the presence of a psychosomatic component and a number of other aspects, the emergence of new drugs for its treatment deserves special attention. The need to take the tablet with water, problems associated with the duration of action and the safety profile of drugs determine the search not only for new drugs for the treatment of ED, but also for dosage forms that can mask the effect of taking the drug, thereby increasing the quality of life of patients. Today, PDE5 inhibitors are produced in the form of oral dispersible tablets, orally dispersible films, nasal sprays, deodorants, and several other forms. It is assumed that the less the quality of a patient’s intimate life depends on the fact of taking the pill, the higher the patient’s possible compliance with the prescribed therapy and, accordingly, the result of treatment.

Since the appearance of sildenafil drugs on the Russian market, i.e. for almost 20 years, sufficient experience has been accumulated in its use by patients with ED. The drug has a known, predictable and controllable clinical effect, as well as a number of well-studied side effects. The clinical efficacy and safety of sildenafil has been confirmed by a significant number of multicenter controlled clinical studies [10, 11], and its effectiveness has been shown in various age populations [12], as well as in the treatment of chronic diseases that provoke the development of ED, such as diabetes mellitus [13].

The use of a dosage form in the form of films deserves special attention, because the drug dissolves in the oral cavity and is the free base of sildenafil, which does not have a bitter taste, unlike its citrate, the active ingredient in tablet forms [14]. Earlier studies showed the bioequivalence of sildenafil films in tablet form. The results of these studies showed their similar bioavailability [1, 2]. Since the pharmacodynamic curve of the tablet and oral dispersible forms is practically the same, it can be assumed that the amount of transit losses will be almost identical for them, and films do not require additional use of liquid to get the drug into the body.

Thus, Dynamic Forward (sildenafil in the form of films dispersible in the oral cavity) is an alternative drug to tablet forms of sildenafil. Dynamic Forward (Teva) is registered in a number of countries, incl. and in the Russian Federation (RF), for the treatment of ED, while data regarding its comparative therapeutic effectiveness with tablet drugs in the Russian population have not yet been obtained, which was the reason for conducting our study.

The purpose of this open-label, multicenter, randomized study was to evaluate the effectiveness and safety of Dynamic Forward in the form of films dispersible in the oral cavity, compared with Viagra and Dynamico in the form of film-coated tablets in the treatment of patients with ED.

The primary endpoints included an assessment of the proportion of patients who, by the end of treatment (week 12), had an IIEF index score in the first domain of ≥26 points or an increase of ≥50% in this index compared to the same indicator at the screening visit.

Material and methods

Study design

The study included 120 male outpatients with ED aged 20 to 70 years, of whom 114 completed the study according to the protocol. Patients were randomized into 3 groups of 40 people. Patients of the first group received Dynamico Forward (sildenafil, films, dispersible in the oral cavity, 100 mg, Teva), the second - Viagra (sildenafil, film-coated tablets, 100 mg, Pfizer), the third - Dynamic (sildenafil, film-coated tablets). coated, 100 mg, Teva) on demand, 1 time per day, the recommended dosage frequency is 2-3 times a week for 12 weeks, followed by dynamic monitoring of residual effects after taking the drugs for 2 weeks. Patients of the 1st group were recommended to place the drug on the tongue until completely dissolved, followed by swallowing; in patients of the remaining groups, tablet drugs were taken as standard. The study was conducted in 6 clinical centers of the Russian Federation.

To assess the clinical effectiveness of the drugs, a physical examination and examination by a urologist were used; sexual history was collected (in the form of filling out the Quality of Sexual Life Questionnaire [QOLQ-M] and the IIEF questionnaire). As parameters for the safety of therapy, vital signs, laboratory and instrumental parameters, as well as the frequency and severity of adverse events (AEs), including serious ones (SAEs), were assessed.

Collection of patient data for each visit

The study consisted of 3 stages: a screening period, a treatment period and a follow-up period. During this time, patients completed 6 visits, the treatment period was 12 weeks, the follow-up period was 14 days, and the maximum study duration was 15 weeks (Fig. 1).

After signing the informed consent, screening measures were carried out and inclusion criteria were assessed, which were the presence of a documented diagnosis of ED made at least 3 months before screening, and a score in the “erectile function” domain of the IIEF questionnaire from 11 to 25 points inclusive (out of 30 possible) at the time of screening. As part of the screening activities, a physical examination of the patient, an examination by a urologist, and a sexual history were also performed. After randomization, patients were prescribed appropriate ED therapy.

In order to assess the safety of therapy, general and biochemical blood tests, a general urinalysis, and an ECG study were performed at the visits, concomitant therapy was recorded, adherence to treatment was assessed, and study drugs were taken into account. At visits 3 and 5, patients additionally filled out the IIEF and OXG-M questionnaires. Visit 6 was conducted to monitor the patients' condition and assess the safety of therapy, after which the study was considered completed for the patient.

Statistics

Statistical significance levels and confidence intervals for the study were calculated as two-sided, with a significance level of 0.025 for treatment effect ratio confidence intervals and 0.05 for other comparisons (unless otherwise noted).

Ethical review

The study (protocol number CS-DYN01-13) was conducted in compliance with the principles laid down in the Declaration of Helsinki of the World Medical Association (1964 with subsequent amendments), in accordance with the requirements of GOST R 52379–2005 “Good Clinical Practice”, ICH GCP rules and current regulatory requirements. The study was approved by the Ethics Council of the Ministry of Health of the Russian Federation.

results

Baseline characteristics of patients in the three groups did not differ significantly (Table 1).

The IIEF index values at the time of inclusion in the study in the Viagra group were 17.13±2.88, Dynamico – 16.68±2.75 and Dynamico Forward – 16.54±3.26. By the end of the study, the frequency of “positive” responses to therapy in the study groups was 55% (95% confidence interval [CI] – 39.82–69.30) in the Viagra group, 75% (95% CI – 62.30–85 .54) in the Dynamico group and 70% (95% CI – 54.47–82.03) in the Dynamico Forward group without significant differences between the groups (p>0.05).

When comparing the effectiveness of Dynamico Forward and Viagra, the statistical hypothesis of “non-inferior effectiveness” of Dynamico Forward was confirmed. When comparing the effectiveness of Dynamic Forward and Dynamic, similar clinical effectiveness indicators were achieved, however, due to an insufficient sample of patients, it was not possible to refute the null hypothesis.

In Fig. Figure 2 shows the dynamics of indicators on the ICEF scale. A statistically significant increase in this indicator compared to the screening indicator was recorded already at visit 3 and remained at visit 5 in all groups of patients. In Fig. Figure 3 shows the average increase in ICEF scores compared to the initial indicators.

The dynamics of secondary effectiveness criteria also did not have significant differences between the groups. Statistically significant increases in scores were detected in all three groups at Visit 3 (in all domains) and persisted until the end of the study.

An increase in indicators of the quality of sexual life was also recorded at visit 3 and remained until the end of the study in all three groups without significant intergroup differences (Fig. 4).

Adherence to therapy was assessed by the number of returned drug packages. If the patient took ≥4 tablets/films of the drug, this indicator was regarded as 100% compliance. In one patient, compliance was 69%, in all others it reached 100%.

Regardless of the use of the study drug, the study recorded 30 AEs in 19 patients (Table 2): 6 while taking Viagra – in 4 patients, 9 while taking Dynamico – in 7 patients and 15 while taking Dynamico Forward – in 8 patients patients. One SAE was reported in one patient. All cases of AEs resolved without consequences.

Gastrointestinal disorders while taking Viagra, AEs of an infectious nature while taking Dynamico and Dynamico Forward, as well as hypotension while taking Dynamico Forward were regarded as unexpected. In terms of severity, all AEs were classified by the researchers as mild in severity and did not require additional drug correction, with the exception of one patient in the Dynamic Forward group with ARVI of moderate severity. In one patient who developed arterial hypotension while taking Dynamic Forward, subsequent dosages of the study drug were reduced by 50%; one patient withdrew his informed consent due to severe nasal congestion, and therefore the drug was discontinued. In other cases, the dose of the study drugs was not changed. One SAE was reported in the study - acute pansinusitis, which developed in a patient taking Viagra. The disease required hospitalization in an ENT hospital and resolved with recovery (it was classified as a SAE due to the patient’s hospitalization). This SAE was considered moderate, unexpected, and not related to the drug. There were no statistically significant differences in AEs between groups.

Discussion

The present study represents one of the first to examine the therapeutic efficacy of a generic form of sildenafil compared to the brand name drug.

The study confirmed the hypothesis of “non-inferiority” for Dynamic Forward and Viagra; the same hypothesis in relation to the second pair of drugs, Dynamic Forward and Dynamic, was not confirmed. At the same time, similar indicators of therapeutic effectiveness were demonstrated in all observation groups. The reason that the null hypothesis for the second pair of drugs was not confirmed in this study may be due to the insufficient sample size of patients. When analyzing the data at the end of the study, it was calculated that to prove the primary hypothesis under the conditions of choosing the most conservative Bonferroni correction, it would have been necessary to include at least 74 patients in each group.

An additional explanation is the significant variability in the primary endpoint observed in this study. A practical explanation for the significant variability in IIEF scale scores may be different interpretations of IIEF scale questions by patients and, as a consequence, significant variability in answers.

There were no statistically significant differences in the effect on the absolute IIEF index in domain 1 between the studied drugs. It is obvious that from a practical point of view, minimal absolute differences in IIEF scores between groups do not reflect clinically significant effects.

The results of this study complement those of bioequivalence studies comparing tablet formulations with oral film formulations [1, 2]. A recent study by E. Dadey showed that preparations in the form of orally dispersible films provide similar plasma concentrations of sildenafil compared to the tablet form [2].

Thus, there is currently data on the bioequivalence of these dosage forms, and the results of the study we presented demonstrate their similar effectiveness and safety. Taking into account the advantages of sildenafil in the form of films (we are talking primarily about the absence of the need to drink the drug with water), these data allow us to consider them a possible alternative to the tablet form in the treatment of a number of patients with ED.

In patients of all three groups, similar, acceptable indicators of tolerability of therapy were established. The number of AEs in the groups did not differ statistically significantly. Also, there was no effect of the study drugs on laboratory parameters, basic vital functions of the body and electrocardiogram parameters. The data obtained during the study correlate with similar indicators of treatment tolerability in earlier studies [1, 2].

In a study by M. Radicioni et al. it was shown that AEs were recorded with the same frequency in groups of patients taking sildenafil in the form of films or tablets [1]. Thus, the results obtained confirm the interchangeability of the studied drugs, both in terms of safety and tolerability, and in terms of effectiveness.

Films dispersible in the oral cavity - Dynamic Forward (Teva, Israel), which have pharmacokinetic and pharmacodynamic properties equivalent to classic sildenafil tablets, have a number of advantages over them. Their use is less noticeable to the patient’s partner, can be “disguised” as taking a “lozenge” for the oral cavity, does not require additional fluid intake, and has a clinical effect comparable to a tablet.

With long-term therapy with PDE-5 inhibitors, discreet administration of the drug becomes crucial for the patient. Taking the drug in an “on demand” mode implies some freedom in choosing a drug to ensure adequate erectile function. If the patient has a ready-made solution for the treatment of ED, then after 30–40 doses of PDE-5 inhibitors in the most convenient “on-demand” mode for him, he, as a rule, ceases to perceive ED as a significant problem, knowing that he can successfully cope with it.

Thus, films dispersible in the oral cavity - Dynamic Forward (Teva, Israel) - have a number of advantages compared to the classic tablet form of sildenafil with a comparable clinical effect and can be recommended for patients with erectile disorders for long-term use.

Conclusion

The use of the drugs Dynamic Forward and Dynamic is comparable in therapeutic effectiveness to the drug Viagra. The study showed non-inferior therapeutic efficacy of Dynamic Forward compared to Viagra and similar therapeutic efficacy compared to Dynamic. All three drugs demonstrated satisfactory tolerability and safety of use.